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February 6, 2005
Pfizer
told U.S.
federal drug officials Friday that studies involving their arthritis
and pain drug
Celebrex showed no evidence of
increased heart problems. Celebrex is one of Pfizer's best-selling
medications, with $3.3 billion in sales last year.
However, the drug data referred to did not include outside studies
that indicated Celebrex raised the risk of cardiovascular events.
Their data was from 41 of its own patient trials, involving close to
44,000 subjects.
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Celebrex belongs to a family of drugs that includes the
Vioxx,
manufactured by
Merck that is currently under
preliminary litigation problems after being pulled from the market and
Bextra, a sister product also made by Pfizer.
On Feb. 16, an
FDA advisory committee will begin
hearings to assess the safety records of COX-2 inhibitors, including
Celebrex, Bextra and Vioxx. The data provided by Pfizer was for the
advisory committee meeting. The panel may advise drug
regulators to take all Cox-2 inhibitors off the market, depending on
their findings.
In December, a trial involving Celebrex to prevent the recurrence of
colon polyps was stopped after the drug increased the risk of heart
attacks and strokes among patients on the medication. |
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The National Institutes of Health
ended a study two months ago after discovering high doses of Celebrex
more than tripled the incidence of heart attacks and strokes.
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Celebrex Information
Celebrex Lawsuits
Pfizer study reported increased
heart risk
Vioxx - Celebrex Panel Drug ties questioned
Celebrex Patient Information Sheet
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